A Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
This is a study in healthy adult subjects to evaluate the bioequivalence of a Combined
Formulated Tablet compared with maraviroc and Combivir administered concurrently versus
maraviroc + Combivir. 42 subjects will be enrolled in the study such that 40 subjects
complete dosing and critical assessments. The total duration of a subject's participation
will be approximately 33 to 35 days, including a screening period (Day -21 to Day -1), 2
treatment periods (Days 1-3), at least a 7-day washout between Period 1 and Period 2, and a
follow-up visit 7 to 14 days after the last dose of study drug in Period 2. Each dosing
period will begin the evening prior to dosing and extend until 48 hours (Day 3) after dosing.
Subjects will be randomly assigned to receive 1 of the following 2 treatments in Period 1
then crossover to receive the alternate treatment in Period 2:
In Sequence 1 (N=21) subjects will receive Treatment A followed by a 7 day washout and
Treatment B. In Sequence 2 (N=21) subjects will receive Treatment B followed by a 7 day
washout and Treatment A. Treatment A consists of 1 tablet of maraviroc 300 mg, lamivudine 150
mg, and zidovudine 300 mg as a combined formulation after an overnight fast. Treatment B
consists of 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an
overnight fast. On Day 1 of each treatment period, subjects will receive study drug in the
morning after an overnight fast of at least 8 hours. Study drug will be administered with 240
mL of water. Dosing in each treatment period will be separated by a minimum washout period of
at least 7 days between doses. All subjects will undergo safety and other assessments.
Subjects may be discharged after all study procedures are completed on the morning of Day 3,
with instructions to return for the next study period or the follow-up visit, as appropriate.
The follow-up visit will occur 7 to 14 days after the last dose of study drug in Period 2.
Pharmacokinetic blood samples will be collected during each treatment period for evaluation
of maraviroc, lamivudine, and zidovudine before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3,
4, 6, 8, 12, 18, 24, 36, and 48 hours after dosing (total of 16 PK time points per treatment
period). Protocol waivers or exemptions are not allowed, with the exception of immediate
safety concerns. Therefore, adherence to the study protocol requirements, including those
specified in the Time and Events Table, are essential and required for study conduct.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Lamivudine Lamivudine, zidovudine drug combination Maraviroc Zidovudine